MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT

Model Number	G56999
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a plastic bag without the pouch or a lot number.Our laboratory evaluation of the product said to be involved confirmed the report.The forceps were returned with the cups cut from the sheath.The cups were not returned with the device.The handle was manipulated and the link wires would not advance or retract.The handle provided no resistance during actuation.The sheath measured at 235.5 cm from the base of the handle to the distal end were the sheath was cut.The link wires are sticking out past the sheath to 238.5 cm.There is severe damage to the sheath between 53 cm and 60 cm, the catheter has been stretched and lost some of it's structure.There is also damage at the distal end of the handle on the sheath.No other anomalies were detected with the device.The device was returned to the supplier for further evaluation.The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.
Event or Problem Description
During a colonoscopy, the physician used a cook captura pro¿ biopsy forceps with spike.It was reported that while doing a colonoscopy, the physician did a surveillance biopsy in the ascending colon.When the physician opened the forceps, the forceps opened but would not close [subject of this report].The device was down the scope but didn't make patient [tissue] contact.The physician had to pull the scope out of the patient and had to cut the biopsy forceps off to remove it from the scope channel.Another of the same product number was used successfully to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a plastic bag without the pouch or a lot number.Our laboratory evaluation of the product said to be involved confirmed the report.The forceps were returned with the cups cut from the sheath.The cups were not returned with the device.The handle was manipulated and the link wires would not advance or retract.The handle provided no resistance during actuation.The sheath measured at 235.5 cm from the base of the handle to the distal end were the sheath was cut.The link wires are sticking out past the sheath to 238.5 cm.There is severe damage to the sheath between 53 cm and 60 cm, the catheter has been stretched and lost some of it's structure.There is also damage at the distal end of the handle on the sheath.No other anomalies were detected with the device.The device was returned to the supplier for further evaluation.The following information was provided: the device was returned in an open pouch type bag.An examination of the device revealed no visual defects , however the device shows extensive damage to the forceps while the forceps cups are missing.Functional evaluation: the device was functionally evaluated.Upon initial evaluation, the complaint from the report is confirmed.During testing, with the device held in straight, u-shape and three-loop coiled positions, respectively, it was confirmed that the device did not operate due to the extensive damage it has received.The forceps were returned with the cups cut from the sheath.The cups were not returned with the device.The handle was manipulated and the link wires would not advance or retract.The handle provided no resistance during actuation.The root cause for the complaint cannot be confirmed due to the damage it has received.The device history records for process traveler (pt) were reviewed.The manufacturing records and/or fqc checklist did not indicate relevant defects.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: the returned device was not functional as a result of the cups missing from the device.A root cause could not be determined.The device was returned with the cups missing.All devices receive a 100% inspection prior to release and shipment.Prior to distribution, all captura pro¿ biopsy forceps are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

• Brand Name: CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE
• Common Device Name: PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 12917981
• Report Number: 1037905-2021-00659
• Device Sequence Number: 12010602
• Product Code: PTS
• UDI-Device Identifier: 00827002569997
• UDI-Public: (01)00827002569997(17)240628(10)W4486181
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2024
• Device Model Number: G56999
• Device Catalogue Number: BF-2.8SJ-230SP-40
• Device Lot Number: W4486181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE - OLYMPUS, MODEL UNKNOWN
• Patient Sex: Unknown